Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrophic or Hypotrophic Endometrium. Basic parameters: 48 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the "chip biopsy" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the "rail biopsy" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability. This observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of "chip biopsy" versus "rail biopsy" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.
Primary outcome measures
- To compare the duration of procedures performed using two different techniques for endometrial biopsy in patients requiring sampling of hypotrophic or atrophic endometrium: 'chip biopsy' and 'rail biopsy' [Time frame: During hysteroscopy]
Secondary outcome measures (6)
- To compare the safety of the procedure between the two endometrial biopsy techniques. [Time frame: During hysteroscopy]
- To compare the adequacy of the tissue obtained for histological analysis between the two endometrial biopsy techniques. [Time frame: Upon delivery of the histological report (within 1 month from hysteroscopy)]
- To compare the need for additional accessory instruments between the two endometrial biopsy techniques. [Time frame: During hysteroscopy]
- Pain intensity assessed by Visual Analog Scale (VAS) [Time frame: administered after hysteroscopy (within 24 hours)]
- Pain quality assessed by McGill Pain Questionnaire (MPQ) [Time frame: administered after hysteroscopy (within 24 hours)]
- Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) [Time frame: administered after hysteroscopy (within 24 hours)]
Eligibility criteria
Inclusion criteria
- Age ≥ 48 years and ≤ 75 years
- Women with atrophic endometrium, candidates for endometrial biopsy
- Informed consent obtained for participation in the study and for the processing of personal data
Exclusion criteria
- Presence of intrauterine fibroids, polyps, and adhesions;
- Current or recent (< 3 months) use of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
- Previous confirmed diagnosis of endometrial cancer;
- Suspected active pelvic inflammation or history of recent pelvic inflammation (< 6 months);
- Presence of severe stenosis or obliteration of the cervical canal.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT07675317 · HYSTEB